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Provided that till the time the standards are notified, the procedure as applicable to other kind of utilization of hazardous and other wastes, as enumerated above shall be followed. The MoEF and Climate Change shall be the nodal ministry to deal with the trans-boundary movement of hazardous and other wastes in accordance with the provisions of these rules.

No import of the hazardous and other wastes from any country to India for disposal shall be permitted. The import of hazardous and other wastes from any country shall be permitted for recycling, recovery, reuse and utilization including co-processing. The import of other wastes in Part-D of Schedule-III will be allowed as per the procedure given in rule 13 and as per the note below the said schedule. No import of hazardous and other wastes specified in Schedule-VI shall be permitted.

The import and export of hazardous and other wastes not specified in Schedule III, but exhibiting the hazardous characteristics outlined in Part C of Schedule III shall require prior written permission of the Ministry of Environment, Forest and Climate Change before it is imported to or exported from India, as the case may be.

This responsibility should be clearly indicated in the manifest. Copy number with colour code. Copy 1 White. To be forwarded by the sender to the State Pollution Control Board after signing all the seven copies. Copy 2 Yellow. To be retained by the sender after taking signature on it from the transporter and the rest of the five signed copies to be carried by the transporter. Copy 3 Pink.

To be retained by the receiver actual user or treatment storage and disposal facility operator after receiving the waste and the remaining four copies are to be duly signed by the receiver. Copy 4 Orange.

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To be handed over to the transporter by the receiver after accepting waste. Copy 5 Green. To be sent by the receiver to the State Pollution Control Board. Copy 6 Blue. To be sent by the receiver to the sender. Copy 7 Grey. To be sent by the receiver to the State Pollution Control Board of the sender in case the sender is in another State. Any person aggrieved by an order of suspension or cancellation or refusal of authorization or its renewal passed by the State Pollution Control Board may, within a period of 30 days from the date on which the order is communicated to him, prefer an appeal in Form 12 to the Appellant Authority namely the Environment Secretary of the State.

Documents required for Hazardous Waste Authorization. Responsibilities of the the occupier for the handling of hazardous waste. Storage of Hazardous Wastes :. The new drug application process is how manufacturers provide evidence to FDA to demonstrate that the new drug product is safe and effective for use as recommended in the product's labeling.

Sometimes, an OTC drug product begins as an approved prescription drug and then a drug company will submit an application to FDA to switch the drug product from prescription status to OTC status. FDA reviews the information in the application, along with information about adverse events associated with the use of the drug, and determines whether the prescription drug can be used safely and effectively as an OTC drug.

FDA allowed nicotine patches and gums, which were initially available by prescription only, to be switched to OTC status between and The nicotine lozenge and mini-lozenge were approved by FDA directly for OTC use in and via new drug applications. FDA has determined that OTC NRTs can be used safely and effectively by people without a healthcare professional's supervision when used in accordance with their label instructions.

This characteristic of FDA-approved OTC NRTs means that nicotine enters the body over a period of time and there is a gradual increase in the level of nicotine in the blood when used in accordance with the accompanying label. Based on the established clinical experience with similar nicotine replacement therapy products, acute toxic reactions would not be anticipated from use of Nicotine Polacrilex Lozenges at the recommended dosage. In summary, the most common dosage of nicotine from OTC nicotine gums and lozenges mg and OTC nicotine patches mg is absorbed slowly and results in significantly lower concentrations of nicotine in blood levels compared to the amount of nicotine that has been determined or estimated to be lethal to animals and humans.

The OTC nicotine patch, the strongest of which contains mg of nicotine, delivers 21 mg of nicotine at a relatively steady rate over a hour period when the patch is applied to the skin. The most frequently reported side effects from use of patches are local skin reactions, which can be reduced by moving the site of the patch application daily as instructed. Following exemption from the P listing, these OTC NRT wastes will be considered non-hazardous wastes and can be managed under applicable non-hazardous solid waste regulations.

The Agency does not have any information at this time to suggest that these wastes will be improperly managed as non-hazardous wastes or have the potential to cause human or environmental exposures. The Agency believes, because of the low concentrations of nicotine in these wastes and their design to slowly release the nicotine, any risk from plausible mismanagement scenarios would not be sufficient to cause a substantial present or potential hazard to human health or the environment.

Nevertheless, the Agency encourages healthcare facilities to first consider if their unused nicotine-containing products, which are to be discarded, can be legitimately recycled to recover the nicotine. The Agency has recently stated to one recycler that legitimately recycled nicotine-containing products would not be considered solid waste and thus would not be subject to RCRA hazardous waste regulation. Therefore, the Agency recommends that healthcare facilities, including retailers, take the necessary security measures to discard unused, unwanted, or expired OTC NRTs where they are not freely accessible to the public.

The recommended security measures could be simple as having locks on the dumpsters and trash cans that are used for discarding OTC NRTs or placing the dumpsters and trash cans in locked areas. There were mixed comments on exempting e-cigarettes, nicotine containing e-liquids, and NRTs requiring a prescription from the P hazardous waste listing when discarded for more information, see Summary of Comments included previously in this section. The comments from retailers, tobacco companies, and trade associations generally favored exempting these categories of products from the P listing when discarded, whereas comments from four of five states and NEWMOA did not support exempting these products from the P listing when discarded.

The e-cigarettes and nicotine-containing e-liquids or just e-liquids are currently not regulated by FDA in the same manner as NRTs. Consequently, the FDA has not been able to evaluate the health risks to the public from e-cigarettes and e-liquids to the same extent as it has been able to for drugs. Moreover, the concentrations of nicotine in e-cigarettes and e-liquids are not limited by any FDA regulation or approval process and are therefore unpredictable.

The Deeming Rule extended FDA's regulatory authority to all tobacco products, including electronic nicotine delivery systems or e-cigarettes. This rule allows FDA to evaluate factors such as ingredients e. The Deeming Rule ensures that newly regulated tobacco products, before they are introduced into the market, meet certain requirements, including warning labels, prohibiting sales to minors, registering with FDA, and obtaining marketing authorization from FDA.

It is, however, important to note that FDA's review and approval process for introducing new tobacco products to the market is not as rigorous in assessing their safe use as review and approval of drug products. Furthermore, in August , the FDA extended the compliance deadline for the newly regulated noncombustible tobacco products in the Deeming Rule, such as e-cigarettes, from November 8, to August 8, Therefore, without controls on the concentration of nicotine in e-cigarettes and e-liquids or FDA's approval of these products as being safe and effective for people to use, the Agency lacks adequate information and certainty to conclude that these nicotine-containing products will not pose the risks similar to those for which the P listing was established.

For all of the above reasons, at this time the Agency cannot support exempting e-cigarettes and nicotine-containing e-liquids from the P listing. Furthermore, in the short time that e-cigarettes have been in the U. This significant increase can be attributed largely to the rapid rise in the use of e-cigarettes by the public. Exposures of children to unregulated nicotine concentrations in e-cigarette cartridges and refill solutions e-liquids have the potential to cause much more severe toxic effects compared to exposures of children to FDA-approved OTC NRTs.

The liquid nicotine, ingested or absorbed through skin, is likely to result in more severe toxic effects because it is available in higher concentrations and absorbed rapidly by the body. In December , a 1-year old child died from liquid nicotine poisoning, the first such death in the U. A prescription for a drug is written by a health professional for an individual at a specific dose after the health professional has diagnosed an illness. Generally, nicotine-containing prescription drugs e.

When a prescription pharmaceutical is transitioned to OTC status, the key question for FDA is whether consumers can achieve the desired medical result without the intervention of a health care professional and without endangering their safety. Therefore, the comments from retailers also expressed less concern about the disposal of prescription NRTs causing a change in their hazardous waste generator category. Based on the information discussed above and the comments from a majority of the states and NEWMOA, the Agency is not exempting e-cigarettes, e-liquids, or prescription NRTs from the P hazardous waste listing.

The Agency believes that any plausible mismanagement or diversion of these waste products, if exempted and allowed to be managed as non-hazardous wastes, has the ability to cause substantial present or potential hazard to human health and the environment. This is because prescription NRT products can contain nicotine at much higher concentrations and in a more readily available form i.

Instead, the Agency is allowing e-cigarettes, e-liquids, and prescription NRTs to be managed as hazardous waste pharmaceuticals under 40 CFR part subpart P when they are discarded. Some commenters stated that the data and information they provided to EPA should be adequate to support a concentration-based exemption for nicotine-containing products.

These commenters requested that EPA exempt from the P listing all present and future nicotine-containing products with less than a particular nicotine concentration e. The Agency stated in the proposal that it would consider a concentration-based exemption for low-concentration nicotine-containing products if toxicology data e. On June 9, , Perrigo submitted additional comments along with oral and dermal LD50 toxicity studies for nicotine gums and lozenges manufactured by Perrigo.

EPA's review of the Perrigo LD50 studies revealed several critical flaws in the way these studies were conducted.

4.3 Hazardous Waste Management

First, the studies were conducted using nicotine polacrilex instead of nicotine itself. A concentration-based listing for nicotine would require toxicity data for nicotine itself. In fact, the nicotine will not release from the nicotine-containing resin nicotine polacrilex until it is exposed to an aqueous solution or proper pH, such as found in saliva. Therefore, nicotine polacrilex would not be expected to be absorbed dermally. In contrast, nicotine is readily absorbed dermally, as indicated by nicotine patches. To support a concentration-based exemption of nicotine, Perrigo should have conducted the toxicity studies for nicotine using the percent of nicotine not nicotine polacrilex in the gums and lozenges, since this would have provided data on toxicity of nicotine the P listed chemical.

Second, for acute oral testing, a single bolus dose of nicotine should have been administered to the test animals all at once or over a short period of time instead of over a period of 24 hours. Fourth, Perrigo did not provide LD50 toxicity data for nicotine patches this could be because Perrigo does not manufacture nicotine patches.

The toxicological data submitted by Perrigo are for nicotine polacrilex, instead of nicotine, and are not considered to be adequate to support a concentration-based exemption for nicotine-containing products. Therefore, the Agency has no other information to conclude that a particular nicotine concentration can be exempt from the P listing. Based on information collected from outreach efforts and comments received on the proposed rulemaking, EPA is finalizing regulations for the reverse distribution of prescription hazardous waste pharmaceuticals, codifying our existing interpretation for the reverse logistics of nonprescription pharmaceuticals, [ 41 ] and establishing a policy for the reverse logistics of other unsold retail items.

The remainder of this section proceeds as follows. First, EPA provides a brief background on the Agency's work to better understand the retail sector and provide guidance on RCRA's applicability to the retail sector. EPA then describes the proposal to revise the Agency's position regarding how RCRA applies to pharmaceuticals that are returned to reverse distributors under the pharmaceuticals proposed rulemaking.

Finally, EPA provides the rationale for finalizing distinct regulations and policies for the reverse distribution of prescription hazardous waste pharmaceuticals and the reverse logistics of other unsold retail items and nonprescription pharmaceuticals and describes new information received in comments on the proposed rulemaking.

EPA's review consisted of discussions with various members of the retail community and states through meetings, conferences, and site visits. EPA's outreach efforts, combined with an analysis of comments received on the NODA, improved the Agency's understanding of the challenges that the retail sector faces when managing items that have become unsalable at stores for a variety of reasons. EPA also noted that a number of questions have been raised by both retailers and regulators regarding how the reverse distribution process is regulated, or should be regulated, under RCRA. In addition, this issue becomes more complicated for national retailers with store locations in multiple states, as states have taken various positions on how RCRA regulations apply.

Because of the challenges facing the retail sector in complying with RCRA, EPA stated in the Retail Strategy its intent to develop a policy addressing the reverse distribution process for the retail sector as a whole. In the Retail Strategy, EPA agreed to develop a comprehensive policy that applied to all unsold retail items, not just pharmaceuticals. In order to fulfill EPA's intent to address the reverse distribution process for the retail sector as a whole, EPA is establishing a policy for the reverse logistics of other unsold retail items in addition to finalizing regulations for the reverse distribution of prescription hazardous waste pharmaceuticals and codifying our existing interpretation for the reverse logistics of nonprescription pharmaceuticals.

In the proposed Management Standards for Hazardous Waste Pharmaceuticals, EPA proposed to revise the Agency's position regarding how RCRA applies to pharmaceuticals that are returned to reverse distributors to obtain manufacturer credit. EPA's interpretation was based on the understanding that the decision to either return goods for reclamation or dispose of them took place only at the manufacturing plant. In the second memo, EPA agreed that pharmaceuticals returned to a manufacturer, wholesaler, or third-party service company would not be considered wastes until a decision to discard has been made.

Thus, the memo describes EPA's interpretation regarding how RCRA applies to pharmaceuticals that are returned to reverse distributors prior to this final rulemaking. In the preamble to the proposed rulemaking, EPA indicated the Agency's intent to modify its position regarding the point of generation in circumstances where a pharmaceutical is sent to a reverse distributor. EPA proposed that the decision to send a pharmaceutical to a reverse distributor is the point at which a decision has been made to discard the pharmaceutical.

This proposed change of policy was based on the EPA's understanding that in almost all cases, pharmaceuticals returned to a reverse distributor for manufacturer credit are ultimately discarded. Therefore, under the proposal, potentially creditable prescription pharmaceuticals and nonprescription pharmaceuticals transported to a facility that facilitates or verifies manufacturer credit, even in cases where a credit determination is yet to be made, would be considered discarded and, therefore, solid wastes at the healthcare facility. In proposing this shift, EPA specifically stated that, although a pharmaceutical may retain monetary value within the reverse distribution system i.

That is, when a pharmaceutical is discarded determines whether it is a solid waste, not whether the pharmaceutical has value. This interpretation is consistent with EPA's approach under RCRA that materials that are discarded are solid wastes, regardless of their monetary value or the economics of the system in which those discarded materials are handled. EPA has long maintained, and continues to maintain, the interpretation that value is not determinative of solid waste status.

In a more recent application of this interpretation, EPA outlined its position on chlorofluorocarbons CFCs that are processed back into the refrigerant market or sent for destruction, but receive carbon offset credits and thus have value, in two memos signed in As another example of a material that is discarded as solid waste but has monetary value, EPA maintains that spent lead acid batteries being reclaimed are regulated as hazardous waste under part subpart G or under universal waste irrespective of the fact that the batteries may have value and that reclamation facilities sometimes buy batteries due to the monetary value of the lead.

Ilco Inc. Additionally, the holdings of multiple court decisions is that simply because a hazardous waste has, or may have, monetary value does not mean the material loses its status as a solid waste. See American Petroleum Institute v. EPA, F. ILCO Inc. Browner, 37 F. In light of comments received on the proposed rulemaking, along with EPA's understanding of current business practices, the Agency is making a clear distinction in the final rule between the reverse distribution of prescription pharmaceuticals and the reverse logistics of other unsold retail items, including nonprescription pharmaceuticals.

In addition to receiving information from comments on the proposed rulemaking, EPA gathered information from site visits and by participating as an observer in the Retail Waste Working Group. However, EPA notes that these tailored RCRA regulations for prescription pharmaceuticals going through reverse distribution are designed with existing business practices in mind. For more explanation, see section 4 below and section XVII of this preamble. EPA is also codifying our existing interpretation for the reverse logistics of nonprescription pharmaceuticals.

EPA received numerous comments on the proposed position that the decision to send potentially creditable pharmaceuticals through reverse distribution is a decision to discard. States were generally supportive of the proposed change in position, while many comments from the retail industry objected to the Agency's proposed change in position. EPA received many broad comments on EPAs proposed position regarding the waste status of pharmaceuticals going through reverse distribution and reverse logistics, which are discussed in further detail in section XVII.

EPA also received many comments describing the potential burden that the revised interpretation would place on the retail industry, which are also discussed in further detail in section XVII. The remainder of this section focuses on comments received on the distinction between the reverse distribution of prescription pharmaceuticals and the reverse logistics of nonprescription pharmaceuticals and other unsold retail items.

EPA received numerous comments that described the key distinctions between reverse distribution and reverse logistics as they pertain to the waste status of pharmaceuticals and other unsold retail items going through these two processes. Multiple commenters argued that EPA mistakenly concluded that pharmaceuticals, including nonprescription pharmaceuticals, transported to facilities that facilitate or verify manufacturer credit are in most, if not all cases, discarded.


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However, commenters did confirm that prescription pharmaceuticals are in Start Printed Page most, if not all cases, discarded. Commenters argued that this fact contradicts EPA's rationale in proposing that all pharmaceuticals, including nonprescription pharmaceuticals, going through reverse distribution and reverse logistics are wastes at the healthcare facility.

Another commenter made a similar argument, writing that the purpose of reverse distribution of prescription pharmaceuticals is to determinate creditworthiness while the primary purpose of reverse logistics of nonprescription pharmaceuticals is to aggregate and redirect viable products into another supply chain. In contrast, most nonprescription pharmaceuticals are not susceptible to the same diversion risks as prescription pharmaceuticals and do not face the same documentation and disposal requirements.

Walmart Stores Inc. Inmar Inc. Overall, these comments help to underscore the differences between how prescription pharmaceuticals and other unsold retail items, including nonprescription pharmaceuticals, are managed within the reverse supply chain. These comments led EPA to make a clear distinction in the final rule between the reverse distribution of prescription pharmaceuticals and the reverse logistics of all other unsold retail items, including nonprescription pharmaceuticals.

EPA acknowledges that reverse distribution and reverse logistics processes share common elements in terms of the role each plays in the management of pharmaceuticals. Prescription pharmaceuticals shipped from healthcare facilities to reverse distributors for the evaluation of manufacturer credit are almost always discarded.

EPA is aware that prescription pharmaceuticals are sometimes lawfully donated, in which case the pharmaceuticals would not be Start Printed Page a solid waste.


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EPA recognizes that the awarding of credit for unsold pharmaceuticals is a critical element of both the reverse distribution and reverse logistics processes as it provides a healthcare facility financial incentive to not only stock a particular pharmaceutical but also to defray costs associated with transporting a pharmaceutical to a reverse distributor or reverse logistics center. Rather, the decision to discard is determinative of when an unsold product becomes a solid waste. In the case of prescription pharmaceuticals, EPA maintains its position, as stated in the proposed rulemaking preamble and reflected in the regulatory text, that prescription pharmaceuticals moving through reverse distribution are solid wastes starting at the healthcare facility.

That is, a pharmaceutical is a solid waste when the decision has been made to discard regardless of whether the pharmaceutical has value. Thus, a decision to send prescription pharmaceuticals to a reverse distributor is a decision to discard the material. None of the comments on the proposed rule alter EPA's position regarding the likelihood of redistribution or reclamation of prescription pharmaceuticals being managed through reverse distribution. Many of the broad comments in support of the proposed reinterpretation provided examples but did not distinguish between prescription pharmaceuticals and nonprescription pharmaceuticals.

For example, multiple commenters argued that pharmaceuticals transported to a reverse distributor are rarely redistributed or reclaimed, and are usually destroyed, but did not explain if this applied only to prescription pharmaceuticals. This commenter was only aware of one instance of potential reuse of a pharmaceutical after being sent through reverse distribution. For example, Walmart argued that the comments EPA received on the Pharmaceutical Universal Waste proposal where pharmaceuticals were defined only as prescription pharmaceuticals and the Retail Notice of Data Availability that pharmaceuticals going through reverse distribution are ultimately discarded were likely talking about prescription pharmaceuticals.

Although the healthcare facility or reverse distributor intends to elicit credit from the prescription pharmaceutical in the interim period before it is sent for treatment, the pharmaceutical is still considered a discarded material. An intent to receive credit does not preclude the pharmaceuticals from being discarded; they are not mutually exclusive. Although EPA maintains its position that prescription pharmaceuticals moving through reverse distribution are solid wastes at the healthcare facility, this final rule establishes streamlined, practical standards for managing potentially creditable hazardous waste pharmaceuticals that will reduce regulatory burden on retailers and align with the existing practices of the retail sector.

Thus, EPA's position that prescription pharmaceuticals moving Start Printed Page through reverse distribution are solid wastes at the healthcare facility only subjects these hazardous waste pharmaceuticals to the streamlined part subpart P standards versus the full RCRA Subtitle C regulations. For example, EPA does not require healthcare facilities to use a hazardous waste manifest or a hazardous waste transporter when shipping potentially creditable hazardous waste pharmaceutical to a reverse distributor.

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See section XVI. D for a discussion of the shipping standards for potentially creditable hazardous waste pharmaceuticals. Because the point of generation of potentially creditable hazardous waste pharmaceuticals is at the healthcare facility, EPA can impose the RCRA Subtitle C cradle-to-grave management of hazardous wastes.

Specifically, it allows us to impose consistent and enforceable tracking of hazardous waste pharmaceuticals from healthcare facilities en route to reverse distributors. Lack of tracking was identified as a regulatory gap by many commenters on our proposal to add pharmaceuticals to the Universal Waste program. The tracking provides the benefit of reducing the risk of diversion of these unused hazardous waste pharmaceuticals onto the black market, thus fulfilling our statutory mandate of protecting human health.

Additionally, the final definition of reverse distributor has been revised so that it applies only to the reverse distribution of prescription pharmaceuticals. In the final rule, EPA is reaffirming the Agency's previous policies on redistribution expressed in memos in and with respect to nonprescription pharmaceuticals and other retail items that have become unsalable at the retail store and are being managed by a reverse logistics center through the reverse logistics process. EPA recognizes that reverse logistics centers are designed to evaluate unsold retail items, analyze secondary markets, and assess the suitability of the unsold retail items for reuse in those secondary markets.

These services promote the donation, liquidation, and reuse of unsold retail items and reduce overall waste. Importantly, these activities are distinct from the activities of reverse distributors of prescription pharmaceuticals. Reverse distributors of prescription pharmaceuticals are not designed to evaluate unsold prescription pharmaceuticals and assess the suitability of the prescription pharmaceuticals for reuse in secondary markets.

As mentioned previously, commenters pointed out that the purpose of reverse distribution of prescription pharmaceuticals is to determinate creditworthiness while the primary purpose of reverse logistics of nonprescription pharmaceuticals is to aggregate and redirect viable products into another supply chain.

Over the years, however, many have come to disregard the intent behind this guidance and erroneously believed that it was a blanket statement that pharmaceuticals going through reverse distribution were not solid wastes, even if they did not have a reasonable expectation of being redistributed or recycled. We strongly encourage the use of reverse logistics centers to facilitate redistribution and legitimate recycling to the fullest extent possible, and thus, reduce the amount of waste being generated. But we also caution reverse logistic centers not to become de facto waste management facilities for their customers.

If this were to occur, it could be the case that the decision to discard for nonprescription pharmaceuticals and other retail items would have occurred at the retail store or healthcare facility. Of course, once a reverse logistics center makes a decision to discard an item, it becomes a solid waste and, if it is listed or exhibits a characteristic, a hazardous waste. The reverse logistics center is subject to the applicable RCRA regulations, such as part , for the generation and accumulation of hazardous waste, including hazardous waste pharmaceuticals, but not part subpart P.

For example, DOT promulgated a final rule in March on the reverse logistics of hazardous materials. This rule includes provisions to help ensure that items, including consumer grade fireworks, are in original packaging when shipped from a retail store to a manufacturer, supplier, or distribution facility. There are six issues that came to EPA's attention when shaping this final reverse logistics policy. The first issue regards the ultimate disposition of unsold retail items moving through reverse logistics.

The second issue regards unsold retail items that have expired. The fifth issue involves instances when nonprescription pharmaceuticals and other unsold retail items become subject to a voluntary, federally mandated, or state mandated recall. The final issue involves instances when nonprescription pharmaceuticals and other unsold retail items cannot be sent through reverse logistics because they are broken, damaged, or leaking.

Unsold retail items returned to the manufacturer or vendor. As noted previously, data from commenters suggests a majority of unsold retail items moving through reverse logistics are returned to the manufacturer or vendor. Unsold retail items that have expired. In addition to information received from commenters suggesting that expired products might be considered eligible for redistribution, FDA occasionally allows the donation of drugs that are past the expiration date shown on the label when provided sufficient information to show the expired pharmaceuticals are safe and effective and other specific criteria have been met.

These items are in their original, intact packaging and do not pose a high risk of release to the environment. Further, this position is consistent with the goal of the RCRA statute to reduce waste, as EPA is concerned that considering unsold retail items that have expired to be wastes at the retail store could introduce an unintended incentive for retailers to remove those items from shelves in advance of expiration dates, resulting in an unnecessary increase in overall waste generation.

Unsold retail items subject to a destroy disposition. However, if a manufacturer has established business rules that do not imply that disposal is the ultimate disposition for unsold retail items, and there is a reasonable expectation the items will be reclaimed, these items would not be solid wastes at the retail store when they are sent through reverse logistics. Thus, a manufacturer can adopt business rules that prohibit the lawful redistribution of retail items for their intended purpose i.

These items would not be wastes at the retail store if there is a reasonable expectation the items will be reclaimed. Crediting process for unsold retail items.

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The fourth issue regards the crediting process for unsold retail items. It is the Agency's understanding that there are two primary credit models. EPA's understanding is that under such an approach, retailers are responsible for managing unsold retail items and determining the ultimate disposition since the manufacturer is not involved in the disposition decision. That being said, retailers can utilize reverse logistics to assist in the management and disposition of unsold retail items sold under an adjustable rate policy. In other words, a pharmaceutical is a solid waste when the decision has been made to discard regardless of whether the pharmaceutical has value.

Thus, for this final action, the credit model is not relevant to the waste status of unsold retail items. Unsold retail items subject to a recall. Almost all pharmaceutical recalls are overseen by FDA. Consumer Product Safety Commission CPSC has authority regarding special packaging sometimes called child resistant packaging of certain household products, including drugs as that term is defined in the Federal Food, Drug, and Cosmetic Act. Additionally, CPSC has jurisdiction over recalls of many other consumer products sold at retail stores.

This is true whether they become subject to a recall at a reverse logistics center, healthcare facility, or retail store. For example, if CPSC oversees a recall if there is a problem with a pharmaceutical's packaging e. Although it is difficult for EPA to make a blanket determination on whether all recalled nonprescription pharmaceuticals and other unsold retail items are or are not solid wastes, EPA is choosing not to apply RCRA regulations to recalled nonprescription pharmaceuticals and other unsold retail items provided the recall is overseen by FDA or CPSC.

When FDA directs the destruction of some or all of the recalled retail items, or CPSC grants permission to dispose or destroy some or all of the recalled items, the materials that are hazardous waste must be managed in accordance with RCRA, including the hazardous waste generator regulations standards in 40 CFR part Although FDA and CPSC are the federal agencies that primarily regulate recalled nonprescription pharmaceuticals and other unsold retail items, other federal agencies regulate some recalled retail items. For example, the National Highway Traffic Safety Administration oversees motor vehicle defects and safety recalls.

CPSC requires manufacturers to develop a recall strategy that outlines all of the actions to be taken on behalf of the manufacturer from start to finish. FDA requires firms that initiate a recall to develop a recall strategy and recommends that firms that initiate a FDA-requested recall develop a recall strategy. However, the Agency will continue to evaluate recalled nonprescription pharmaceuticals and other unsold retail items managed by other federal agencies on a case-by-case basis.

Finally, while EPA is not applying RCRA regulations in these situations, we note that if recalled nonprescription pharmaceuticals and other unsold retail items are not managed and stored in a manner that prevents release to the environment, they may be considered a solid waste and a hazardous waste under sections , , and of RCRA.

Unsold retail items that are broken, damaged, or leaking.

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The sixth issue involves instances when nonprescription pharmaceuticals and other unsold retail items cannot be sent through reverse logistics because they are broken, damaged, or leaking. CVS commented on the proposed rulemaking and asked that EPA clarify that when pharmaceutical packaging is in sufficiently poor condition that it is broken, leaking, or otherwise unable to be used for its intended purpose, that those pharmaceuticals become solid waste at the healthcare facility.

Although EPA affirms the resulting settlements and agrees that nonprescription pharmaceuticals and other retail items cannot be sent through reverse logistics when they are broken, damaged, or leaking, the Agency is aware that there is inherent uncertainty Start Printed Page surrounding when these items are considered broken, damaged, or leaking.

For example, a nonprescription pharmaceutical could experience damage to the outer packaging while the inner container remains intact. Thus, the Agency intends that nonprescription pharmaceuticals and other unsold retail items can be sent to a reverse logistics center and are not considered wastes at the retail store if they meet this standard. For example, if an outer cardboard box containing vials of nonprescription pharmaceuticals is damaged, but the vials are intact and not damaged or leaking, EPA does not consider the item to be damaged such that it cannot go through reverse logistics.

In order to prevent exposures to personnel, the public, and the environment, if items are not in good condition, or are leaking or releasing to the environment, these items must be managed as wastes at the stores in accordance with the applicable hazardous waste regulations. Specifically, if the broken, damaged, or leaking item is a hazardous waste pharmaceutical, the retail store must manage it under the streamlined standards of part subpart P unless it is a VSQG for all its hazardous waste.

Otherwise, the retail store would manage hazardous wastes under the applicable RCRA regulations, including part generator regulations.

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Additionally, consistent with legislative history, when evaluating the American Retail Federation's petition, EPA determined that it was necessary to establish two criteria that must be met to qualify for this exclusion. First, the waste must be generated by individuals on the premises of a temporary or permanent residence and, second, the waste stream must be composed primarily of materials found in wastes generated by consumers in their homes.

In this final rule, EPA denied the American Retail Federation's petition to exempt consumer household hazardous waste generated by retail sources because these wastes fail to meet both criteria. The Agency reaffirmed this position in the Retail Strategy, arguing that retail goods, including those that could become wastes when discarded, do not satisfy the criteria for this exclusion.

The Agency believes that this interpretation extends to retail items purchased by a customer and subsequently returned to a retail store. Hazardous waste generated at retail stores, including retail items purchased by a customer that are subsequently returned, does not meet the first criterion for the household hazardous waste exemption. Specifically, the decision to discard does not occur at the residence, it occurs at the retail store.

In fact, many retail items that are returned are restocked and sold at the store e. On the other hand, the Agency notes that a household pharmaceutical that is collected from individuals by a healthcare facility e. This final rule is a sector-based rule that applies to the management of hazardous waste pharmaceuticals that are generated and managed by healthcare facilities and reverse distributors.

Subsequent sections of the preamble will discuss in detail the definitions of these terms, as well as what provisions of the rule apply to each type of facility see section VIII for a discussion of each definition and section IX for Applicability. Healthcare facilities and reverse distributors will use the regulations finalized under 40 CFR part subpart P in lieu of the RCRA generator regulations in 40 CFR part to which they were previously subject.

Part subpart P does not apply to the management of hazardous waste pharmaceuticals that are generated by pharmaceutical manufacturers. A pharmaceutical manufacturer remains subject to part and all applicable RCRA subtitle C regulations for the management of its hazardous waste, including its hazardous waste pharmaceuticals.

Pharmaceutical manufacturers do not face the same challenges that healthcare facilities experience when managing hazardous waste pharmaceuticals in accordance with the federal RCRA subtitle C regulations for an explanation of the challenges healthcare facilities face, see discussion in section III of the preamble.

The types of hazardous waste pharmaceuticals generated by manufacturers are less variable and therefore more predictable, and the staff have the necessary expertise to determine which pharmaceutical waste is hazardous waste. However, when any facility, including a pharmaceutical manufacturer, meets the definition found in this proposal for a reverse distributor, it would be subject to the final regulations for reverse distributors with respect to those operations.

The Agency emphasizes that the regulatory requirements in this final rule do not apply to households that discard pharmaceuticals. Pharmaceuticals that are discarded by households are not regulated as hazardous waste and are generally considered municipal solid waste. While a small percentage of these Start Printed Page household waste pharmaceuticals meet the definition of hazardous waste under RCRA, the federal RCRA hazardous waste regulations include an exclusion for all hazardous wastes generated by households. As a result, for household hazardous waste collected at a household hazardous waste collection program, the Agency has historically recommended that communities operating the collection programs manage the collected household hazardous waste as hazardous waste, even though it is not required by RCRA.

Similarly, the Agency recommends that, whenever possible, households utilize pharmaceutical collection events as the preferred disposal option for their unwanted pharmaceuticals. In a memo, the Agency recommended that collected household waste pharmaceuticals be incinerated— preferably at a permitted hazardous waste incinerator, but when that is not feasible, at a large or small municipal waste combustor. This final rule is a sector-specific rulemaking that applies to healthcare facilities and reverse distributors.

As such, this final rule does not apply other generators of hazardous waste pharmaceuticals such as farmers, ranchers, and fisheries. Although these businesses might administer pharmaceuticals to their animals in the regular course of their business, they would not fall within the definition of a healthcare facility or a reverse distributor. The Agency designed this final rule to address the unique needs of the healthcare sector and concluded that it would not be appropriate to apply it to all sectors that generate hazardous waste pharmaceuticals.

Other generators of hazardous waste pharmaceuticals, such as farmers, ranchers and fisheries, remain subject to the part generator regulations. As discussed in detail in section VIII of this preamble, the definition of healthcare facility does include veterinary clinics and veterinary hospitals. This final rule does not affect how RCRA-permitted or interim status TSDFs manage hazardous waste pharmaceuticals at their facilities, except indirectly when they treat hazardous waste pharmaceuticals to meet the land disposal restrictions LDRs.

See section X. These final regulations pertain only to those pharmaceutical wastes that are RCRA hazardous wastes that are generated by healthcare facilities or managed by reverse distributors. Under this rulemaking, EPA has not added additional pharmaceuticals to the hazardous waste listings or expanded the hazardous waste characteristics to include additional pharmaceuticals. Although we solicited ideas from commenters for possible methods or approaches for regulating additional pharmaceuticals as hazardous waste, any action taken to address the comments we received in response to this request would be a separate action taken by the Agency in the future and is not part of this final rulemaking.

The generation, accumulation, transportation, treatment, storage, and disposal of hazardous waste pharmaceuticals are regulated under RCRA Subtitle C. However, hazardous waste pharmaceuticals may also be subject to a number of other statutes and implementing regulations administered by state or other federal agencies. Examples include pharmaceuticals that are subject to the Controlled Substances Act and DEA regulations; infectious pharmaceutical wastes that are subject to state and local medical waste regulations; pharmaceuticals with a radioactive component that are subject to the Atomic Energy Act AEA and pharmaceuticals that are hazardous waste as defined in 40 CFR These potentially overlapping requirements make the appropriate management of pharmaceutical wastes a complex matter.

The following discusses the impact of this final rule on various dually regulated hazardous waste pharmaceuticals. Controlled substances. That is, this final rule eliminates the dual regulation for RCRA hazardous waste pharmaceuticals that are also DEA controlled substances. A more detailed discussion of this conditional exemption is found in section XIV of this final rule. Medical wastes. There are instances when a hazardous waste pharmaceutical will also pose a biological hazard.

As a result, the healthcare facility must send these dual wastes to a hazardous waste TSDF that is also permitted by their state to accept medical wastes. Some examples of dual wastes include partially administered syringes containing hazardous waste pharmaceuticals e. The RCRA hazardous waste pharmaceutical component of these dual wastes are included within these final subpart P management standards so that healthcare facilities can obtain the benefits of this new subpart, while ensuring the hazardous waste component of the waste is managed appropriately and ultimately delivered to RCRA-permitted TSDFs.

EPA notes that autoclaving alone is not an acceptable method of treating hazardous wastes pharmaceutical or non-pharmaceutical that are also medical waste. Hazardous waste pharmaceuticals with a radioactive component. Therefore, if a healthcare facility that manages hazardous waste pharmaceuticals encounters specific RCRA requirements that are inconsistent with specific AEA requirements, only the AEA requirements would apply.

It is important to note, however, that the determination of an inconsistency would relieve the healthcare facility only from compliance with the specific RCRA requirement s that is deemed inconsistent with the AEA requirement s ; the healthcare facility would still be required to comply with all of the other hazardous waste pharmaceutical management standards.

Clean Air Act. In general, the Clean Air Act protects human health and the environment from the harmful effects of air pollution by requiring reductions in the emissions of air pollutants. These pollutants, which are known or suspected to cause serious health problems, such as cancer or birth defects, are referred to as hazardous air pollutants HAPs and include several metals that are found in pharmaceuticals, such as selenium, mercury, and chromium compounds.

These standards vary based on the type of hazardous waste combustion source e. This is usually where site-specific circumstances indicate that a MACT standard is not protective of health and the environment. These regulations established emission limits for nine substances or mixtures i. The emission limits are based on the application of MACT and reflect the emission levels achieved by the best performers in each category.

Because each state law was slightly different, it made compliance difficult for companies operating in multiple states. Section specifically avoids preempting state requirements, such as RCRA hazardous waste laws, that are unrelated to the tracing of products within the prescription drug distribution supply chain and other issues expressly addressed by the DSCSA. EPA's position is based upon our review of both the direct language and intent of the statute. To understand the connection between state hazardous waste regulations and the DSCSA, it is important to understand the relationship between the federal and state hazardous waste regulations.

Authorized state hazardous waste regulations must, at a minimum, be equivalent to federal RCRA hazardous waste regulations. Such an implied repeal would leave gaps in RCRA coverage and result in no hazardous waste regulations of any kind—federal or state—applying to the documentation of the management of hazardous waste pharmaceuticals. The general rule enunciated by the U.

These commenters believed that, at a minimum, the mere fact that a pharmaceutical product becomes nonsaleable does not mean that such pharmaceutical product is now a solid waste under the RCRA hazardous waste regulations. EPA does not agree with these comments. The purpose of the DSCSA is to protect the security, pedigree, and quality of pharmaceutical products in the drug supply chain. As explained in further detail throughout this preamble, whether a pharmaceutical has monetary value such as when it receives manufacturer credit is not determinative of whether it is a waste under RCRA.

Under RCRA, one considers whether a material is discarded—and not whether it receives credit, or holds value or no value—to determine whether it is waste. Thus, prescription pharmaceuticals that are sent by healthcare facilities to reverse distributors and that will be discarded even if these pharmaceuticals receive credit will first be considered wastes at the healthcare facility when the decision is made by the healthcare facility to send them to a reverse distributor.

Furthermore, EPA disagrees with commenters that a nonsaleable pharmaceutical product sent to reverse distributors should not be considered a waste. Nonsaleable pharmaceutical products sent to reverse distributors are not sent for reuse or donation, but are sent for disposal, and thus would be considered wastes at the healthcare facility.

Trading partners are dedicated to moving products forward for dispensing and administration to patients. Returns processors' activities come at the end, when the product is no longer retained for distribution or dispensing and is safely removed from the supply chain. Accumulated, stored, or treated but not recycled before or in lieu of being abandoned by being disposed of, burned, or incinerated. Additionally, in a memo EPA includes a series of questions to help determine whether a commercial chemical product is a solid and hazardous waste. One set of questions relates to whether the facility appears to be selling into commerce the material being evaluated.

If the facility has no customers or market for the material, it can be an indication that the material is a solid waste. As explained elsewhere in the preamble, EPA distinguishes between reverse distributors as defined in this rule and reverse logistics centers. Reverse distributors do not reuse or donate, but in fact, dispose of the pharmaceuticals they receive. Furthermore, since 3PLs, such as reverse logistics providers, do not take ownership of the drugs that they manage at their facilities, the DSCSA requirements related to tracing drugs Start Printed Page through the supply chain, including transaction information TI , transaction history TH , and transaction statements TS , do not apply to them.

In the absence of relevant FDA regulations, it is difficult for EPA to consider the possibility of deferring to FDA for the regulation of reverse distributors, who we consider to be managing hazardous wastes. Wastes that are not included in the scope of this proposed rulemaking include non-hazardous wastes and non-pharmaceutical hazardous wastes. Pharmaceutical wastes that are not listed or characteristic hazardous wastes under RCRA Subtitle C may nonetheless pose some risks to public health and the environment. These wastes are discussed further below.

This final rule, therefore, does not require that healthcare facilities manage these waste pharmaceuticals under the RCRA Subtitle C hazardous waste regulations, including this final rule. However, a healthcare facility may choose to manage its non-hazardous and hazardous waste pharmaceuticals together as hazardous waste pharmaceuticals under the new subpart P regulations.

Because all healthcare facilities operating under this subpart are regulated in the same way regardless of quantity of hazardous waste pharmaceuticals generated, managing non-hazardous waste pharmaceuticals as hazardous waste under this subpart would not affect the facility's hazardous waste generator category. The following summarizes the recommended BMPs found in the Blueprint for various categories of pharmaceutical wastes, including those wastes that possess hazardous waste-like qualities yet are not regulated as hazardous waste under RCRA Subtitle C.

Recommended best management practices for healthcare facilities managing non-hazardous waste pharmaceuticals possessing hazardous waste-like qualities. Currently, most pharmaceuticals are not regulated as RCRA hazardous wastes when discarded by healthcare facilities. As outlined in the Blueprint, there are pharmaceuticals that possess hazardous waste-like qualities, but for various reasons, are not regulated by the RCRA Subtitle C hazardous waste regulations.

The Agency supports the Blueprint's recommendation of hazardous waste incineration as the BMP for healthcare facilities and reverse distributors discarding pharmaceuticals that may possess hazardous waste-like qualities, but are not regulated as RCRA hazardous waste. Recommended best management practices for other non-hazardous waste pharmaceuticals not possessing hazardous waste-like qualities. As far as other non-hazardous waste pharmaceuticals i. Therefore, EPA endorses the Blueprint's recommendation of municipal solid waste incineration or medical waste incineration for any non-hazardous waste pharmaceuticals, even when they do not possess hazardous waste-like qualities.

The potential risk remains for active pharmaceutical ingredients APIs to be released into the environment if medical waste autoclaves or municipal solid waste landfills are used for the purposes of pharmaceutical waste treatment and disposal. For example, autoclaves are designed to kill pathogens and do not achieve the temperatures required to destroy most APIs during the autoclaving process. As a result, when wastewater is generated either by cleaning an autoclave, or during automatic blow down from autoclaves equipped with steam generators, there is the potential for wastewater containing APIs to be generated and discharged into the sewer.

In addition, some limited studies have shown APIs present in landfill leachate collected in municipal solid waste landfill leachate Start Printed Page systems. These newly promulgated subpart P regulations will pertain only to hazardous waste pharmaceuticals. Therefore, other types of hazardous wastes generated at healthcare facilities and reverse distributors that do not meet the definition of a hazardous waste pharmaceutical cannot be managed in accordance with this new subpart as previously discussed, non-hazardous waste pharmaceuticals may be managed under this new subpart.

For example, hazardous wastes generated in hospital laboratories or during cleaning and maintenance of the facility are not considered hazardous waste pharmaceuticals and are not included within the scope of this final rule. The generation of non-pharmaceutical hazardous wastes is often more routine and does not trigger the same concerns that healthcare facilities experience when managing hazardous waste pharmaceuticals. Also note that the Hazardous Waste Generator Improvements final rule added new flexibility for episodic generators of non-pharmaceutical hazardous waste under part subpart L.

In particular, stakeholders requested that the Agency take a broad view in delineating what items are included in the definition of pharmaceutical so that the proposed standards applied broadly. Many commenters argued that personal protective equipment and clean-up material should not be included in the final definition. One commenter suggested that loose tablets be included in the definition of pharmaceutical but that personal protective equipment should not be included.